Device Desk

Private service · Not FDA

FDA device establishment · San Jose, CA

This page shows the yearly renewal for this site, from FDA’s public record.

Device Desk is a private service. We are not FDA. We never file or pay for you.

Renewal dossierDD-2953749As of September 30, 2026

Align Technology, Inc.

Registration 2953749FEI 3002519584San Jose, CA

Owner/operator: Align Technology, Inc.

  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

Renewal due by December 31, 2026

Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.

90days left in the window

The 2026 window

  1. Oct 1Window opens91 days left
  2. Nov 3Where you stand58 days left
  3. Dec 1Our pay-by date30 days left
  4. Dec 15Two weeks left16 days left
  5. Dec 23Holiday week8 days left
  6. Dec 29Two days left2 days left
  7. Dec 31Window closes0 days left
an email on that date our pay-by date to December 31
FDA fee, FY2027
$13,785
Our pay-by suggestion
Dec 1
Listed devices
29
Added, last 12 months
6

FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page

The steps, in order

  1. Pay FDA's annual feeYou

    Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.

    FDA: registration and listing payment process

  2. Wait for the payment confirmation numberYou

    FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.

    FDA: registration and listing payment process

  3. Renew the registration in FDA's systemYou

    Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.

    FDA: device registration and listing

  4. Review every listingYou

    In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.

    FDA: device registration and listing

Every listed device 29

CodeDeviceClassRegulationPremarket
NXCInvisalign AssistAligner, SequentialClass 221 CFR 872.5470K981095
NXClnvisalign Specifix Attachment SystemAligner, SequentialAdded Nov 18, 2025Class 221 CFR 872.5470K252870
NXCInvisalign Pre-Formed Attachment SystemAligner, SequentialClass 221 CFR 872.5470K222894
NXCInvisalign Palatal ExpanderAligner, SequentialClass 221 CFR 872.5470K232887
NXC3D Treatment Planning Software - ClinCheck Pro 6Aligner, SequentialClass 221 CFR 872.5470K220287
NXCInvisalign System with Integrated ButtonAligner, SequentialClass 221 CFR 872.5470K252380
NXC3D Treatment Planning Software - ClinCheck Pro 6Aligner, SequentialClass 221 CFR 872.5470K181739
NXC3D Treatment Planning Software - ClinCheck Pro 6Aligner, SequentialClass 221 CFR 872.5470K232233
NXCInvisalign Palatal ExpanderAligner, SequentialAdded Nov 17, 2025Class 221 CFR 872.5470K252931
NXC3D Treatment Planning Software - ClinCheck Pro 6Aligner, SequentialClass 221 CFR 872.5470K241412
QJKiTero Lumina ProIntraoral CameraClass 221 CFR 872.3661K240573
NTKiTero Lumina ProLight Transmission Caries DetectorClass 221 CFR 872.1745K240573

and 17 more on your full dossier

What changed

  • Nov 18, 2025Listing added: NXC — lnvisalign Specifix Attachment System (K252870)
  • Nov 17, 2025Listing added: NXC — Invisalign Palatal Expander (K252931)
  • Aug 3, 2026Listing added: NTK — iTero Lumina Pro (K261847)
  • Nov 17, 2025Listing added: PNN — Invisalign Palatal Expander (K252931)
  • Jan 29, 2026Listing added: QJJ — Attachment Template
  • Nov 18, 2025Listing added: DYT — lnvisalign Specifix Attachment System (K252870)
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov). FDA does not endorse Device Desk.FDA’s own record is always the authority.

How we got this date

  1. FDA asks every device site to renew its registration each year.
  2. The renewal window runs from October 1, 2026 to December 31, 2026.
  3. A renewal in this window covers 2027.
  4. The rule is 21 CFR 807.22(b).

FDA’s record shows this registration runs through 2026.

We read this from FDA’s public record on September 30, 2026.

Read FDA’s page on registration

Watch for mail that looks like it is from FDA and asks you to pay a company. You pay FDA’s fee only in FDA’s own system.

Keep this desk: $249 a year

We keep this page current each week. We email you before each date in the window, and when FDA’s record shows you renewed.

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Renews each year until you cancel. Cancel any time from your account.

Is this right?

We copy this from FDA’s public record. FDA’s own record always wins. A listing missing here does not prove anything about FDA’s record.

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